UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006359 |
|---|---|
| Receipt number | R000007549 |
| Scientific Title | Clinical efficacy of azithromycin for male urethritis |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2013/10/03 14:48:45 |
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Basic information
Public title
Clinical efficacy of azithromycin for male urethritis
Acronym
Clinical efficacy of azithromycin for male urethritis
Scientific Title
Clinical efficacy of azithromycin for male urethritis
Scientific Title:Acronym
Clinical efficacy of azithromycin for male urethritis
Region
| Japan |
Condition
Condition
male urethritis
Classification by specialty
| Infectious disease | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of clinical efficacy of azithromycin for the patients with male urethritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
eradication of causative microorganism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
azithromycin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
male patients with urethritis
Key exclusion criteria
male patients; cannot administer the drug, cannot revisit clinic, have some allergy with azithromycin
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Takahashi |
Organization
Sapporo Medical University Hospital
Division name
Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
stakahas@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Takahashi |
Organization
Sapporo Medical University Hospital
Division name
Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
stakahas@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌医科大学付属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 03 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 16 | Day |
Last modified on
| 2013 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007549
